What are the responsibilities and job description for the Project Leader position at Medinext Global LLC?
Position Description:
Position Title - Project Leader
Job Location - Skaneateles Falls, NY, USA
Bill Rate Range - $90 to $95
Estimated Duration (In Months) - 8
Work Model - Onsite
Must have Skills/Attributes - Clinical, Data Analysis, Program management, Regulatory
Shift - Monday to Friday, 8 to 5
Required Education:
• Bachelor''s degree in a scientific field
Required Skills:
• Clinical Research Experience: 4–5 years of clinical research experience (including 1–2 years as a Clinical Project Manager)
• Regulatory Knowledge: Knowledge of FDA, ICH/Google Cloud Platform, and global regulatory requirements
• Clinical Trials: Understanding of clinical trial phases (Phase 1–4)
• Clinical Systems: Experience with clinical systems (EDC, CTMS, eTMF)
• Project Management: Strong project management skills
• Cardiac Knowledge: Knowledge of arrhythmias, ECG interpretation, or ambulatory cardiac monitoring systems
• Data Interpretation: Ability to interpret diagnostic performance metrics (e.g., sensitivity, specificity, PPV/NPV) and translate findings into clinical insights
• Risk Assessment: Experience assessing risk/benefit and clinical implications of algorithm performance differences
• Algorithm/Device Knowledge: Familiarity with algorithm-based diagnostics or AI/ML-driven medical devices
• Regulatory Validation: Understanding of validation requirements for medical devices (e.g., EU MDR, FDA expectations)
• Soft Skills: Proactive, collaborative, and self-driven with a take-charge attitude
Job Responsibilities:
• Partner with relevant Baxter functions to develop clinical study plan for each project including timelines and budgets for the clinical program
• Prepare directly or facilitate preparation of study documentation including protocols, case report forms, informed consent, enrollment feasibility evaluations, and all relevant internal plans required for study conduct
• CRO Management (when applicable): Lead the day-to-day oversight of the CRO personnel plus the project budget, deliverables, and timeline/milestones
• Site Activities (either directly or managing others): Identify and assess study sites, conduct investigator meetings and site training, prepare and execute research agreements, and negotiate study budgets
• Study Monitoring (either directly or managing others): Formulate clinical monitoring plan, perform study initiation visits, manage clinical study monitoring resources, oversee standard interim monitoring visits and closeout activities
• Perform study closeout procedures, directly or through other resources, including accurate completion of critical documents, disposition of study product, and preparation of study sites for regulatory authority audits
• Develop and maintain tracking systems as needed for study management (e.g., screening, enrollment, study completion, serious adverse events, budgets and forecasts, milestones)
Salary : $90 - $95